The Acute Effect of Statins on Inflammatory Markers of NCT00587717

Updated 05/31/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00587717
Other study ID #	485-02
Secondary ID	Merck #02005
Status	Completed
Phase	N/A
First received
Last updated
Start date	September 2002
Est. completion date	March 2006

Study information
Verified date	December 2023
Source	Mayo Clinic
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

This study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy

Recruitment information / eligibility
Status	Completed
Enrollment	35
Est. completion date	March 2006
Est. primary completion date	March 2006
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: - Patients undergoing carotid endarterectomy - No previously known side effects of statins - Patients who will sign an informed consent - Age > 18 years old - No signs of current infection Exclusion Criteria: - Patient hypersensitive to any component of this medication - Patients with acute liver disease (AST> normal value) - Patients with chronic liver disease (history of Hepatitis B or C) - Patients with renal failure (creatinine > 3.0) - Patients with unexplained muscle pains and aches - Patients with rheumatoid arthritis - Patients with Lupus - Current cancer treatment - Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone - Pregnant females

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• simvastatin
Two 80 mg pills simvastatin taken 24 hours prior to surgery
• placebo
take 2 80 mg pills placebo 24 hours prior to surgery

Locations
Country	Name	City	State
n/a

Sponsors *(2)*
Lead Sponsor	Collaborator
Mayo Clinic	Merck Sharp & Dohme LLC

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure.		24 prior to surgery

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT02124928` - Morphological and Serological Criteria of Plaque Vulnerability: Risk Assessment for Symptomatic and Asymptomatic Carotid Artery Stenosis	N/A
	Active, not recruiting	`NCT01597453` - NOR-SYS: The Norwegian Stroke in the Young Study	N/A
	Completed	`NCT00744523` - Proximal Protection With The Mo.Ma Device During Carotid Stenting	N/A
	Completed	`NCT00231231` - Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)	Phase 3
	Completed	`NCT00597974` - Neurological Outcome With Carotid Artery Stenting	N/A
	Completed	`NCT02536378` - POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
	Completed	`NCT02126982` - Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence
	Active, not recruiting	`NCT01445613` - Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy	N/A
	Terminated	`NCT01414387` - Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting	N/A
	Completed	`NCT00406055` - CHOICE: Carotid Stenting For High Surgical-Risk Patients	Phase 4
	Completed	`NCT00403078` - SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
	Terminated	`NCT01968226` - TRACER RGD-K5 Carotid Plaque Imaging Study	Phase 2
	Completed	`NCT01685567` - Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure	Phase 3
	Completed	`NCT00402740` - Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)	N/A
	Completed	`NCT00287508` - Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)	Phase 4
	Completed	`NCT00178672` - A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease	Phase 4
	Recruiting	`NCT02850588` - SVS VQI TransCarotid Revascularization Surveillance Project
	Completed	`NCT02759653` - Norwegian Carotid Plaque Study
	Withdrawn	`NCT01042912` - Frequency Analysis of Carotid Artery Disease	N/A
	Completed	`NCT00530504` - Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study	N/A

External Links

Mayo Clinic Clinical Trials